Transvenous Tricuspid Valve Replacement With Lux Valve Plus System in Tricuspid Regurgitation

What is the Purpose of this Study?

The purpose of this study is to evaluate the safety and performance of an experimental device called the LuX-Valve Plus System in people who have severe leaks or regurgitation around the tricuspid valve of their heart and who are at high risk for surgical treatment. The tricuspid valve is the valve on the right side of the heart that controls blood flow from the upper and lower right chambers of the heart. The LuX-Valve Plus is designed to replace the patient’s diseased natural tricuspid valve and consists of a tri-leaflet valve (3 moving tissue parts made from cow heart tissue), delivery system to deliver the implant to the diseased tricuspid valve position, introducer kit used to facilitate the insertion of delivery system, and stabilizer to support the whole delivery system. Participants will undergo the tricuspid valve replacement procedure and clinic visits.

Eligibility

* Age ≥18 years at time of consent
* Severe or greater TR assessed on transthoracic echocardiography by Echocardiography Core Lab using a 5-grade classification (Mild, Moderate, Severe, Massive, Torrential).
* New York Heart Association (NYHA) Class II-IV
* The Patient is being treated on optimal dosage for diuretics at investigator discretion

Inclusion Criteria:

* Age ≥18 years at time of consent
* Severe or greater TR assessed on transthoracic echocardiography by Echocardiography Core Lab using a 5-grade classification (Mild, Moderate, Severe, Massive, Torrential).
* New York Heart Association (NYHA) Class II-IV
* The Patient is being treated on optimal dosage for diuretics at investigator discretion
* The Site Heart Team concur the patient is not an optimal candidate for surgical treatment and it is anatomically suitable for transcatheter tricuspid valve replacement
* Patient must be able to fully understand all aspects of the investigation that are relevant to the decision to participate and provide a written informed consent

Exclusion Criteria:

* Left Ventricular Ejection Fraction (LVEF) \<35%
* Pulmonary arterial systolic pressure (PASP) \>60 mmHg by echo Doppler (unless right heart catheterization \[RHC\] demonstrates PASP ≤60mmHg); or Right heart catheterization OR PASP \>2/3 systemic BP with PVR \>5 Wood units after vasodilator challenge, in the absence of symptomatic hypotension or systolic BP \<90 mmHg.
* Evidence of intracardiac mass, thrombus, or vegetation
* Ebstein Anomaly or congenital right ventricular dysplasia
* Surgical correction is indicated for other concomitant valvular disease (subjects with concomitant valvular disease may treat their respective valve first and wait 2 months before being reassessed for the trial)
* Patients with valve prostheses implanted in the tricuspid valve
* Pre-existing prosthetic valve(s) (other than tricuspid ones) with clinically significant prosthetic dysfunction
* Active infection, infective endocarditis or sepsis within 3 months, or infections requiring antibiotics treatment within two weeks prior to planned procedure
* Untreated clinically significant coronary artery disease requiring revascularization
* Acute myocardial infarction or unstable ischemia-related angina within 30 days prior to the planned procedure
* Any percutaneous coronary, intracardiac or carotid intervention within 30 days prior to the planned procedure
* Any coronary or intracardiac or carotid intervention within 30 days prior to the planned procedure
* Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support TRINITY-US Trial #: Ver 1.0, 14 Nov 2023, Confidential Page 7 of 8
* Cerebrovascular stroke (ischemic or bleeding) within prior 3 months to enrollment
* Active peptic ulcer or active gastrointestinal bleeding within prior 3 months to enrollment
* Blood dyscrasias as defined: leukopenia (WBC \<1000 mm3), thrombocytopenia (platelet count \<50,000 cells/mm3), history of bleeding diathesis, or coagulopathy
* Inability to tolerate anticoagulation or antiplatelet therapy
* Severe liver failure
* Renal insufficiency (eGFR \<30 mL/min \[per the Cockcroft-Gault formula\] and/or renal replacement therapy)
* Uncontrolled atrial fibrillation (e.g., resting heart rate \>120 bpm)
* Pregnancy or intent to become pregnant prior to completion of all protocol follow-up requirements
* Severe Chronic Obstructive Pulmonary Disease requiring steroids or requiring continuous home oxygen
* Untreatable hypersensitivity or contraindication to any of the following: all antiplatelets, all anticoagulants, nitinol alloys (nickel and titanium), bovine tissue, glutaraldehyde, or contrast media
* Estimated life expectancy \<12 months.
* Subjects currently participating in another clinical trial of an investigational drug or device that has not yet completed its primary endpoint
* Patients with current history of illicit drug use
* Any other condition making it unlikely the patient will be able to complete all protocol procedure and follow-ups determined by the investigator

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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

TRIal to Evaluate TraNsvenous TrIcuspid Valve ReplacemenT with Lux Valve Plus System in Patients with Severe or Greater Tricuspid Regurgitation - Safety and Clinical Performance PROTOCOL NO: JSNL-CIP-TVS02-01FDA

Study Details

Disease Type/Condition

Other

Principal Investigator

Makkar, Rajendra

Age Group

Adult

Phase

III

IRB Number

STUDY00003771

ClinicalTrials.gov ID

NCT06568003

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

clinicaltrials@cshs.org